Necrotizing EnterocolitisNCT01807858
The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants
A study testing Bifidobacterium lactis, Bifidobacterium lactis plus İnülin and Maltodextrin in people with Necrotizing Enterocolitis and Sepsis, run by Dr. Sami Ulus Children's Hospital at 4 sites in Turkey (Türkiye).
Trial summary
Study, the inclusion of very low birth weight premature infants followed in Dr.Sami Ulus Maternity and Children Training and Research Hospital, Department of Neonatology; be randomized to very low birth weight premature infants began eating until you are discharged from the hospital once a day to feed a group+ 900 mg… Read more about this study
- Who is it for?
- Ages Up to 30 daysHealthy volunteers can take part
- Conditions the study is for
- Necrotizing Enterocolitis, Sepsis
- What is being tested?
- Bifidobacterium lactis, Bifidobacterium lactis plus İnülin and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 4 sitesTurkey (Türkiye)
- Study dates
- Oct 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 30 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- VLBW infants admitted to NICU at the first 7 days of life
Who cannot join
- expected life lower than 7 days,
- babies who could not be fed (any metabolic disorders, gastrointestinal system surgical disorders etc.),
- severe asphyxia,
- severe congenital anomaly
Trial locations and contacts
4 sites in 1 country.
Dilek Dilli, Assoc Prof contact
Turkey (Türkiye)4 sites, 4 recruiting
- Recruiting
Şevket Yılmaz Research Hospital
Bursa
Arzu Akdağ, MD
Arzu Akdağ, MD
- Recruiting
Diyarbakır Research Hospital
Diyarbakır
Banu Mutlu, MD
M. Şah Oğuz, MD
- Recruiting
Okmeydani Research Hospital
Istanbul
Özden Turan, MD
Özden Turan
- Recruiting
Umraniye Research Hospital
Istanbul
Şenol Bozdağ, MD
Şenol Bozdağ
About this study
Study, the inclusion of very low birth weight premature infants followed in Dr.Sami Ulus Maternity and Children Training and Research Hospital, Department of Neonatology; be randomized to very low birth weight premature infants began eating until you are discharged from the hospital once a day to feed a group+ 900 mg of 5 billion active Bifidobacterium lactis, the addition of chicory inulin, in the other group given placebo; Patients taking weekly blood cultures, the presence of residues in both groups during feeding, to evaluate the incidence of NEC and sepsis are planned. Randomization and the number of patients planned to separate into groups.
Read the detailed description
Patients separated into four groups using the sealed envelope method.
- Conditions
- Necrotizing Enterocolitis, Sepsis
- Being tested
- Bifidobacterium lactis, Bifidobacterium lactis plus İnülin, Maltodextrin, İnulin
- Keywords
- Necrotizing enterocolitis, Sepsis, Length of hospital stay, Mortality
- Medical subject headings
- Enterocolitis, Necrotizing, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium lactisDietary supplement
5 billion active Bifidobacterium lactis
Bifidobacterium lactis plus İnülinDietary supplement
Also called 5 billion Bifidobacterium lactis plus 900 mg İnülin
5 billion Bifidobacterium lactis plus 900 mg İnülin per day will be given
MaltodextrinOther
Maltodextrin
İnulinDietary supplement
900 mg inulin per day will be given
| Study group | Role | What they receive |
|---|---|---|
| Bifidobacterium lactis | Active comparator | 5 billion Bifidobacterium lactis Receives: Dietary Supplement: Bifidobacterium lactis plus İnülin; Other: Maltodextrin; Dietary Supplement: İnulin |
| İnulin | Active comparator | 900 mg İnulin per day will be given Receives: Dietary Supplement: Bifidobacterium lactis; Dietary Supplement: Bifidobacterium lactis plus İnülin; Other: Maltodextrin |
| Maltodextrin | Placebo comparator | Maltodextrin Receives: Dietary Supplement: Bifidobacterium lactis; Dietary Supplement: Bifidobacterium lactis plus İnülin; Dietary Supplement: İnulin |
| Bifidobacterium lactis plus İnülin | Active comparator | 5 billion active Bifidobacterium lactis plus 900 mg İnülin per day Receives: Dietary Supplement: Bifidobacterium lactis; Other: Maltodextrin; Dietary Supplement: İnulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Necrotizing enterocolitis
Developing of >= grade 2 necrotizing enterocolitis suggested by radiological investigation
Measured: 8 weeks
Secondary outcomes (1)
length of hospital stay
length of hospital stay
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startOct 2012
- Primary completionOct 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Necrotizing EnterocolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Sami Ulus Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Dilli, Dr. Sami Ulus Children's Hospital
- Investigators
- Dilek Dilli, MD, Principal investigator, Assoc Prof
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807858
- Sponsor's protocol ID
- 68/16.Oct.2012
- Status last verified
- Mar 2013
- First submitted
- 24 Dec 2012
- Last updated
- 8 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fouhy F, Ross RP, Fitzgerald GF, Stanton C, Cotter PD. Composition of the early intestinal microbiota: knowledge, knowledge gaps and the use of high-throughput sequencing to address these gaps. Gut Microbes. 2012 May-Jun;3(3):203-20. doi: 10.4161/gmic.20169. Epub 2012 May 1.
PubMed 22572829Dilli D, Aydin B, Fettah ND, Ozyazici E, Beken S, Zenciroglu A, Okumus N, Ozyurt BM, Ipek MS, Akdag A, Turan O, Bozdag S. The propre-save study: effects of probiotics and prebiotics alone or combined on necrotizing enterocolitis in very low birth weight infants. J Pediatr. 2015 Mar;166(3):545-51.e1. doi: 10.1016/j.jpeds.2014.12.004. Epub 2015 Jan 13.
PubMed 25596096
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants
- ClinicalTrials.gov ID
- NCT01807858
- Acronym / sponsor ID
- 68/16.Oct.2012
- Conditions
- Necrotizing Enterocolitis, Sepsis
- Keywords
- Necrotizing enterocolitis, Sepsis, Length of hospital stay, Mortality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Dr. Sami Ulus Children's HospitalUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 8 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study, the inclusion of very low birth weight premature infants followed in Dr.Sami Ulus Maternity and Children Training and Research Hospital, Department of Neonatology; be randomized to very low birth weight premature infants began eating until you are discharged from the hospital once a day to feed a group+ 900 mg of 5 billion active Bifidobacterium lactis, the addition of chicory inulin, in the other group given placebo; Patients taking weekly blood cultures, the presence of residues in both groups during feeding, to evaluate the incidence of NEC and sepsis are planned. Randomization and the number of patients planned to separate into groups.
Detailed description
Patients separated into four groups using the sealed envelope method.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bifidobacterium lactis | Active comparator | Dietary Supplement: Bifidobacterium lactis plus İnülin, Other: Maltodextrin, Dietary Supplement: İnulin5 billion Bifidobacterium lactis |
| İnulin | Active comparator | Dietary Supplement: Bifidobacterium lactis, Dietary Supplement: Bifidobacterium lactis plus İnülin, Other: Maltodextrin900 mg İnulin per day will be given |
| Maltodextrin | Placebo comparator | Dietary Supplement: Bifidobacterium lactis, Dietary Supplement: Bifidobacterium lactis plus İnülin, Dietary Supplement: İnulinMaltodextrin |
| Bifidobacterium lactis plus İnülin | Active comparator | Dietary Supplement: Bifidobacterium lactis, Other: Maltodextrin, Dietary Supplement: İnulin5 billion active Bifidobacterium lactis plus 900 mg İnülin per day |
Who may qualify
- Ages
- Up to 30 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- VLBW infants admitted to NICU at the first 7 days of life
Key exclusion criteria (4 listed)
- expected life lower than 7 days,
- babies who could not be fed (any metabolic disorders, gastrointestinal system surgical disorders etc.),
- severe asphyxia,
- severe congenital anomaly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bifidobacterium lactis5 billion active Bifidobacterium lactis | Dietary supplement | Bifidobacterium lactis plus İnülin, Maltodextrin, İnulin |
| Bifidobacterium lactis plus İnülinAlso: 5 billion Bifidobacterium lactis plus 900 mg İnülin5 billion Bifidobacterium lactis plus 900 mg İnülin per day will be given | Dietary supplement | Bifidobacterium lactis, Maltodextrin, İnulin |
| MaltodextrinMaltodextrin | Other | Bifidobacterium lactis, Bifidobacterium lactis plus İnülin, İnulin |
| İnulin900 mg inulin per day will be given | Dietary supplement | Bifidobacterium lactis, Bifidobacterium lactis plus İnülin, Maltodextrin |
Primary outcome
Necrotizing enterocolitis
Time frame: 8 weeks
Developing of >= grade 2 necrotizing enterocolitis suggested by radiological investigation
1 secondary outcome
length of hospital stay
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2013.
- Background: PubMed 22572829Fouhy F, Ross RP, Fitzgerald GF, Stanton C, Cotter PD. Composition of the early intestinal microbiota: knowledge, knowledge gaps and the use of high-throughput sequencing to address these gaps. Gut Microbes. 2012 May-Jun;3(3):203-20. doi: 10.4161/gmic.20169. Epub 2012 May 1.
- Derived from this study: PubMed 25596096Dilli D, Aydin B, Fettah ND, Ozyazici E, Beken S, Zenciroglu A, Okumus N, Ozyurt BM, Ipek MS, Akdag A, Turan O, Bozdag S. The propre-save study: effects of probiotics and prebiotics alone or combined on necrotizing enterocolitis in very low birth weight infants. J Pediatr. 2015 Mar;166(3):545-51.e1. doi: 10.1016/j.jpeds.2014.12.004. Epub 2015 Jan 13.
- Are Probiotics Safe For Newborns? \| LIVESTRONG.COMLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dilek Dilli, Assoc Prof contact
Dilek Dilli, MD principal investigator
Assoc Prof
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bifidobacterium lactis, Bifidobacterium lactis plus İnülin and Maltodextrin in people with Necrotizing Enterocolitis and Sepsis, run by Dr. Sami Ulus Children's Hospital at 4 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dilek Dilli, Assoc Prof (00903123055000), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Necrotizing enterocolitis (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01807858, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2013.